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Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) (PRO-Go)

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ClinicalTrials.gov Identifier: NCT03944785
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Brief Summary:
This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO.

Condition or disease Intervention/treatment
Idiopathic Parkinson Disease Drug: XADAGO (safinamide)

Detailed Description:

This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication.

This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.


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Study Type : Observational
Estimated Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Safinamide

Group/Cohort Intervention/treatment
Parkinson's Disease Patients
PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert
Drug: XADAGO (safinamide)
XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.
Other Names:
  • XADAGO
  • safinamide




Primary Outcome Measures :
  1. Change from baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Baseline to Study Day 60 ]
    MDS-UPDRS is a 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items) examines non-motor experiences of daily living, Part II (13 items) examines motor experiences of daily living, Part III (33 items) examines the cardinal motor disabilities of PD, and Part IV (6 items) examines motor complications. Each item has 0-4 ratings, where 0 (normal) to 4 (severe) and scores for each part is summed to calculate the total scores. The total score ranges from 0 to 260, with higher scores indicating worse outcomes.

  2. Change from baseline in Parkinson's Disease Questionnaire (PDQ-39) scores [ Time Frame: Baseline to Study Day 60 ]
    PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale, with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with the maximum score of 156. Higher scores indicate worse outcomes.

  3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score. [ Time Frame: Baseline to Study Day 60 ]
    MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.

  4. Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) scores [ Time Frame: Baseline to Study Day 60 ]
    TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 30, with higher scores indicating better treatment satisfaction.

  5. Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline to Study Day 60 ]
    CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from 1 (very much improved) through to 7 (very much worse).

  6. Patient Global Impression of Change (PGI-C) [ Time Frame: Baseline to Study Day 60 ]
    PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).


Secondary Outcome Measures :
  1. Change from baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    MDS-UPDRS is a 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items) examines non-motor experiences of daily living, Part II (13 items) examines motor experiences of daily living, Part III (33 items) examines the cardinal motor disabilities of PD, and Part IV (6 items) examines motor complications. Each item has 0-4 ratings, where 0 (normal) to 4 (severe) and scores for each part is summed to calculate the total scores. The total score ranges from 0 to 260, with higher scores indicating worse outcomes.

  2. Change from baseline in Parkinson's Disease Questionnaire (PDQ-39) scores [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale, with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with the maximum score of 156. Higher scores indicate worse outcomes.

  3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score. [ Time Frame: Baseline to treatment extension period visits on study day 180 ]
    MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances.

  4. Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline to study day 30; treatment extension period visits on day 90, day 120 and day 180 ]
    TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 30, with higher scores indicating better treatment satisfaction.

  5. Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from 1 (very much improved) through to 7 (very much worse).

  6. Patient Global Impression of Change (PGI-C) [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease patients who have been newly prescribed XADAGO
Criteria

Inclusion Criteria:

  1. Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.
  2. Patient with diagnosis of idiopathic PD (all stages).
  3. Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.
  4. Patient is willing and able to participate in the study and complete study-related assessments for 2 months and, patients can continue for an optional 4-month study extension.
  5. Patient has access to an electronic device for the interim completion of PROs.
  6. Patient has an available Care Partner who is able and willing to assist with clinic attendance and completion of study assessments (e.g., PROs, health outcomes, etc.), if in the PI's opinion, assistance is needed to comply with all study visits and procedures.

Exclusion Criteria:

  1. Any of the warnings, precautions, or contraindications listed in the XADAGO Package Insert that in the opinion of the PI would prevent appropriate treatment with XADAGO or impair study participation (e.g., pregnancy, lactation, severe hepatic impairment, etc.).
  2. Participation in any other clinical trial of an investigational drug or device within 4 weeks prior to the Baseline Visit or at any time during the study.
  3. Patient is currently receiving chemotherapy or radiation for any form of cancer (if history of cancer, must be in clinical remission at study entry) or currently receiving immunotherapy.
  4. Patients with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate or severe dementia as determined by the clinician (not to include mild cognitive impairment [MCI]); major psychiatric illness (specifically diagnosis of schizophrenia, bipolar disorder or a history of attempted suicide); and/or severe and progressive medical illness (including terminal cancer, end-stage renal disease +/- undergoing dialysis).
  5. Severe or unpredictable dyskinesia at the time of the Baseline Visit.
  6. Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944785


Contacts
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Contact: Jenny Kersey 850-819-9896 jkersey@usworldmeds.com

Locations
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United States, Alabama
Alabama Neurology Associates Recruiting
Homewood, Alabama, United States, 35244
United States, California
Jeri Yvonne Movement Disorders Neurology, Inc. Recruiting
Bakersfield, California, United States, 93312
B.E.S.T. Center of Orange County Recruiting
Laguna Hills, California, United States, 92653
Kaiser Permanente San Leandro Recruiting
San Leandro, California, United States, 94577
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Neuron Research Recruiting
Naples, Florida, United States, 34108
Parkinson's Disease Treatment Center of SW Florida Recruiting
Port Charlotte, Florida, United States, 33980
Sarasota Memorial Hospital Clinical Research Cener Recruiting
Sarasota, Florida, United States, 34239
United States, Illinois
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
United States, Louisiana
Southeast Neuroscience Center, LLC Recruiting
Gray, Louisiana, United States, 70359
United States, New York
Neurological Associates of Long Island, PC Recruiting
Lake Success, New York, United States, 11042
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
United States, North Carolina
Novant Health Neurology - Hickory Recruiting
Hickory, North Carolina, United States, 28602
United States, Ohio
Dayton Center for Neurological Disorders Recruiting
Centerville, Ohio, United States, 45459
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma Recruiting
Tulsa, Oklahoma, United States, 74137
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29615
United States, Texas
Covenant Medical Group Recruiting
Lubbock, Texas, United States, 79410
Texas Institute for Neurological Disorders Active, not recruiting
Sherman, Texas, United States, 75092
Baylor Scott and White Health Recruiting
Temple, Texas, United States, 76508
United States, Virginia
Meridian Clinical Research, LLC Recruiting
Norfolk, Virginia, United States, 23502
United States, Washington
Puget Sound Neurology Recruiting
Tacoma, Washington, United States, 98409
Sponsors and Collaborators
US WorldMeds LLC
Investigators
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Principal Investigator: Bob James, PharmD, MBA US WorldMeds LLC

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Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT03944785     History of Changes
Other Study ID Numbers: USWM-SA1-4001
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by US WorldMeds LLC:
Parkinson's disease
Safinamide
Xadago
MAO-B inhibitor
off
non-motor symptoms
motor symptoms
levodopa
PD

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs